Protocol safely guides perioperative management of dabigatran

A specified protocol to guide perioperative management of dabigatran in patients who underwent invasive procedures appeared effective and safe, according to study results presented at the International Society of Thrombosis and Haemostasis Congress.

Perioperative management of dabigatran in clinical practice varies greatly, according to study background.

Sam Schulman, MD, FRCPC(C), professor in the division of hematology and thromboembolism at McMaster University in Ontario, Canada, and colleagues assessed the safety of perioperative management of dabigatran (Pradaxa, Boehringer Ingelheim) with a specified protocol.

Sam Schulman

The analysis included 542 patients scheduled to undergo invasive procedures.

Schulman and colleagues used creatinine clearance and the bleeding risks associated with each procedure to determine the timing of the final pre-surgery dabigatran dose. The protocol prespecified the timing of dabigatran resumption based on the complexity of each procedure and potential consequences of bleeding complications.

The investigators followed patients for 30 days.

Major bleeding served as the primary outcome. Secondary endpoints included minor bleeding, arterial thromboembolism and death.

Sixty percent of patients (n = 342) underwent procedures associated with standard bleeding risk, and 40% (n = 218) underwent procedures with increased bleeding risk.

Nearly half (46%) of patients received their final pre-procedure dabigatran dose 24 hours prior to surgery and about one-third (37%) received their final dose 48 hours prior to surgery. Six percent of patients received their final dose 96 hours before surgery.

Dabigatran resumption occurred a median of 1 day (interquartile range, 0-2) after surgery. The protocol guided the timing of dabigatran resumption in 77% of cases. Forty percent of patients received 75 mg for their first post-procedure dose.

Results showed 10 patients (1.8%; 95% CI, 0.7-3) experienced major bleeding and 28 patients (5.2%; 3.3-7) experienced minor bleeding events. One patient (0.2%; 95% CI, 0-0.5) experienced transient ischemic attack. No other thromboembolic complications occurred.

Four patients died, but all deaths were unrelated to thrombosis or bleeding.

The investigators did not use bridging preoperatively, but they used it postoperatively in nine cases (1.7%). – by Mark Leiser

For more information:

Schulman S, et al. Abstract OR282. Presented at: International Society of Thrombosis and Haemostasis 2015 XXV Congress; June 20-25, 2015; Toronto.

Disclosure: Schulman reports research or grant support from Baxter, Boehringer Ingelheim and Octapharma, as well as consultant roles for Bayer, Boehringer Ingelheim and Bristol-Myers Squibb. Please see the abstract for a list of all other researchers’ relevant financial disclosures.